A new type of drug called Reloxin appears safe and effective in reducing forehead wrinkles, a new study finds.

The use of Botox to reduce forehead wrinkles and frown lines has long been a mainstay of cosmetic medicine. The medication works by preventing face muscles from contracting, an effect that lasts for several months.

As an alternative to Botox, Reloxin is now approved in 23 countries outside the United States to smooth wrinkles, the researchers noted. The drug has also been used outside the United States for more than 15 years to treat neurological disorders.

One of the differences between Botox and Reloxin is that Reloxin has less protein in its formula, noted Kamran Jafri, MD, from Jafri Craniofacial Plastic Surgery, New York City. Reloxin also contains fewer antigens, which cause the drug to break down more quickly, said Jafri, who was not involved in the new study. "Theoretically, because Reloxin has less of a protein load, the body will break it down at a slower rate. That means from a clinical perspective that it should last longer than Botox," he said. "However, some of the early trials are showing that Botox actually lasts longer than Reloxin."

Another difference between the drugs is that Reloxin defuses more in the tissue than Botox, Jafri said. "Botox typically defuses in about a one centimeter radius. Reloxin can go anywhere from one to three centimeters," he said. "That's a good thing for the forehead, where you can give fewer injections, but it's a bad thing for, say, crow's-feet, where unless you are an experienced injector and you know the muscles very well, it could spread to other muscles and cause a droopy eyebrow or droopy eyelid," he explained.

In this phase III trial, Reloxin's wrinkle-smoothing effects lasted more than 13 months. And although the drug is still awaiting approval from the U.S. Food and Drug Administration, it could someday become a serious competitor to Botox, the researchers said.

"Reloxin is as safe and it works as well as Botox," said lead researcher Ronald Moy, MD, from the Moy-Fincher Medical Group in Los Angeles. "Many of our patients are happier and got a more natural look with the use of Reloxin. I think this will be as popular as Botox, which is the most common cosmetic procedure in the United States."

But not all plastic surgeons are as enthusiastic, with some citing a heightened incidence of drooping of the eyelid and/or brow with Reloxin vs. Botox. "With this study, I don't see a clear advantage over Botox," said Jeffrey C. Salomon, MD, an assistant clinical professor of plastic surgery at Yale University School of Medicine.

The report, which was funded by the drug's maker, Medicis Pharmaceutical Corp., is published in the March/April issue of the Archives of Facial Plastic Surgery. For the study, Moy's team treated 1,200 patients with injections of Reloxin (Clostridium botulinum toxin type A-hemagglutinin complex) in five sites in the forehead. Patients kept diaries of the effects of the treatment and were surveyed a week to 10 days after treatment. In addition, patients were reexamined two weeks and 30 days later, and then each month after treatment.

Among the 1,052 patients who completed the 13-month study, there were 2,838 adverse events among 880 patients. Of these, 28% were probably related to the treatment. These included problems at the injection site, nervous system disorders such as headache and eye problems including ptosis, a drooping of the eyelid or brow. Only one patient withdrew from study due to the side effects of the drug, the researchers say.

Patients reported the drug started working within a day after treatment. After a week, as many as 95% of the patients reported showing a response to the medication. At 30 days after treatment, as many as 91% of the patients had a response, according to the researcher's assessment.

Brent Moelleken, MD, a plastic and reconstructive surgeon in Beverly Hills and Santa Barbara, California, noted that Reloxin has not yet been compared head-to-head with Botox. "The safety profile appears similar to Botox, but perhaps more drooping than is usual with Botox," Moelleken said. "The big question about how Reloxin works, the volume of distribution, was not addressed, or technical differences, which may account for the greater drooping than most injectors see with Botox."

For his part, Salomon said he is concerned with the increased incidence of ptosis [with Reloxin] and the lack of specificity of that ptosis—brow versus lids. "If it is all lid ptosis, then I would consider it as an unintended spread of the material beyond the desired treatment area. That would not be a helpful or predictable component in the product's use," he said.

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